Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT02163720
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer', 'timeFrame': 'Patient will be followed during 12 months', 'description': 'To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.'}], 'secondaryOutcomes': [{'measure': 'Choice of treatment', 'timeFrame': 'at baseline', 'description': 'Describe the reason why treatment by trabectedin and doxorubicine combination was initiated (ex : number of patients with previous intolerance to platinum as allergic reaction, residual peripherical neuropathy, alopecia; availability of the combination yondelis-caelyx in the treating site; number of sites where the yondelis-caelyx combination is the reference treatment)'}, {'measure': 'Characteristics of the population registered', 'timeFrame': 'at baseline', 'description': 'Describe the population that will be registered'}, {'measure': 'Evaluation of the modality of use of Yondelis®-Caelyx®', 'timeFrame': 'during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator', 'description': 'Describe the way how treatment by Yondelis®-Caelyx® is administered in the daily practice for each patient (Initial dosage of caelyx and yondelis, number of cycles administered for each treatment , dose reductions occurence and reasons)'}, {'measure': 'Safety according to CTCAE v4.03 criteria', 'timeFrame': 'Patient will be followed during 12 months', 'description': 'To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.'}, {'measure': 'Evaluation of clinical benefit', 'timeFrame': 'baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.', 'description': 'Evaluation of clinical benefit will be performed during the physical examination at baseline and during the treatment\n\nAt baseline : describe the number of patients how present the following related symptom disease : weight loss, ascites, abdominal pain, constipation, fatigue, occlusive syndrome\n\nThen, describe the number of patients how presented and improvement or a degradation of theses related symptom disease during the treatment\n\nNota Bene : this cohort study is strictly observational and must represent the daily practice. No indications must be given regarding the frequency of the physical examination'}, {'measure': 'Efficacy of treatments', 'timeFrame': 'during treatment and follow up period (maximum of 12 months)', 'description': 'Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'fallopian tube or primary peritoneal', 'relapse', 'platinum-sensitive', 'Yondelis®-Caelyx®'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '32620635', 'type': 'RESULT', 'citation': 'Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.'}]}, 'descriptionModule': {'briefSummary': 'The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.', 'detailedDescription': 'Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and over,\n* Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive\n* Patients should be informed of the study orally and should not have any objection their data to be processed\n\nExclusion Criteria:\n\n* Patient participation in a clinical trial\n* Patient non-affiliated to a social security scheme.'}, 'identificationModule': {'nctId': 'NCT02163720', 'briefTitle': 'Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)', 'organization': {'class': 'OTHER', 'fullName': 'ARCAGY/ GINECO GROUP'}, 'officialTitle': 'Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse', 'orgStudyIdInfo': {'id': 'PROSPECTYON (GINECO-OV229)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Yondelis®-Caelyx®-relapse ovarian cancer', 'description': 'Yondelis®-Caelyx®-relapse ovarian cancer', 'interventionNames': ['Drug: Yondelis®-Caelyx®']}], 'interventions': [{'name': 'Yondelis®-Caelyx®', 'type': 'DRUG', 'otherNames': ['Observation of Yondelis®-Caelyx® administration'], 'description': 'Observation of Yondelis®-Caelyx® administration', 'armGroupLabels': ['Yondelis®-Caelyx®-relapse ovarian cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Agen', 'country': 'France', 'facility': "Centre de Radiothérapie et d'Oncologie", 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'city': 'Amiens', 'country': 'France', 'facility': "Clinique de l'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'ICO Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Hôpital de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Tivoli', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Hôpital Fleyriat', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital Morvan - Centre Hospitalier Universitaire', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': "Cabinet d'Oncologie - Hôpital Privé Sainte Marie", 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'city': 'Cholet', 'country': 'France', 'facility': 'Centre Hospitalier de Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '07500', 'city': 'Guilherand-Granges', 'country': 'France', 'facility': 'Hôpital Privé Drôme Ardèche - Clinique Pasteur', 'geoPoint': {'lat': 44.93278, 'lon': 4.87372}}, {'zip': '28630', 'city': 'Le Coudray', 'country': 'France', 'facility': 'Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 1.50057}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'institut Paoli Calmette', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Mougins', 'country': 'France', 'facility': 'Centre Azuréen de Cancérologie', 'geoPoint': {'lat': 43.60068, 'lon': 6.99523}}, {'city': 'Nancy', 'country': 'France', 'facility': "Centre d'oncologie de Gentilly", 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Orléans', 'country': 'France', 'facility': 'Centre Hospitalier Régional', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Clinique Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Reims', 'country': 'France', 'facility': 'Institut Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Clinique Armoricaine de Radiologie', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Cyr-sur-Loire', 'country': 'France', 'facility': "Clinique de l'Alliance", 'geoPoint': {'lat': 47.4, 'lon': 0.66667}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'ICO Centre René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '31240', 'city': 'Saint-Jean', 'country': 'France', 'facility': "Clinique de l'Union", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}, {'zip': '60309', 'city': 'Senlis', 'country': 'France', 'facility': 'GHPSO - Site Senlis', 'geoPoint': {'lat': 49.20724, 'lon': 2.58661}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre de Radiothérapie - Clinique Sainte-Anne', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulon', 'country': 'France', 'facility': 'Clinique Saint Jean', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut de Cancérologie Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Frédéric SELLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Tenon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCAGY/ GINECO GROUP', 'class': 'OTHER'}, 'collaborators': [{'name': 'PharmaMar', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}